Antihistamine to prevent hypotensive transfusion reactions after blood-primed cardiopulmonary bypass in children
Prophylactic Antihistamine for Prevention of Hypotensive Transfusion Reaction After Blood Primed Cardiopulmonary Bypass in Pediatric Cardiac Surgery: a Randomized-controlled Study
PHASE4 · Kasr El Aini Hospital · NCT07536152
This randomized, double-blind trial will test whether a single IV dose of chlorpheniramine given after separation from cardiopulmonary bypass can prevent hypotensive transfusion reactions in children aged 1–7 undergoing elective repair of acyanotic congenital heart defects.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 1 Year to 7 Years |
| Sex | All |
| Sponsor | Kasr El Aini Hospital (other) |
| Locations | 1 site (Giza, October) |
| Trial ID | NCT07536152 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled trial at a university hospital enrolling 40 children undergoing elective repair of acyanotic congenital heart defects with blood-primed cardiopulmonary bypass. Patients are randomized 1:1 (20 per group) to receive a single intravenous dose of combined chlorpheniramine or normal saline immediately after separation from bypass and before protamine administration. Key inclusion criteria are age 1–7 years and acyanotic congenital heart disease, while exclusions include redo surgery, antihistamine allergy, significant bleeding disorders, and emergency procedures. The study will monitor hemodynamic responses and transfusion-related adverse reactions to see if prophylactic antihistamine reduces hypotensive transfusion reactions and is safe in this setting.
Who should consider this trial
Good fit: Ideal candidates are children aged 1–7 with acyanotic congenital heart defects scheduled for elective repair using blood-primed cardiopulmonary bypass who have no antihistamine allergy, significant bleeding disorder, or planned redo/emergency procedure.
Not a fit: Children outside the 1–7 age range, those with cyanotic defects, redo or emergency cases, active bleeding disorders (INR > 1.5 or platelets < 50,000), or known antihistamine allergy are unlikely to be eligible or to benefit from this intervention.
Why it matters
Potential benefit: If successful, a single dose of chlorpheniramine could lower the risk of hypotensive transfusion reactions and improve blood pressure stability during recovery after bypass in young children.
How similar studies have performed: Antihistamines are widely used to treat allergic transfusion reactions, but randomized data specifically showing prevention of hypotensive transfusion reactions after blood-primed pediatric CPB are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acyanotic congenital heart disease. * Age :1 -7 years. * Genre: both. Exclusion Criteria: * Redo patient. * History of allergy to antihistamines. * Bleeding disorders with INR \> 1.5 and/or platelets \< 50,000. * Emergency procedure.
Where this trial is running
Giza, October
- Misr Universty for Scince and Technology — Giza, October, Egypt (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Blood Transfusion Associated Adverse Reactions, prevention of hypotensive transfusion reaction